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Randomized Controlled Trial
. 2020 Mar 9;12(3):168.
doi: 10.3390/toxins12030168.

Botulinum Toxin Therapy for Managing Sleep Bruxism: A Randomized and Placebo-Controlled Trial

Young Joo Shim  1 , Hee Jin Lee  2 , Keun Jeong Park  2 , Hyung Tack Kim  3 , Il Hee Hong  4 , Seong Taek Kim  5
Affiliations
Randomized Controlled Trial

Botulinum Toxin Therapy for Managing Sleep Bruxism: A Randomized and Placebo-Controlled Trial

Young Joo Shim et al. Toxins (Basel). .

Abstract

The purpose of this study is to evaluate the effects of botulinum toxin type A (BoNT-A) for managing sleep bruxism (SB) in a randomized, placebo-controlled trial. Thirty SB subjects were randomly assigned into two groups evenly. The placebo group received saline injections into each masseter muscle, and the treatment group received BoNT-A injections into each masseter muscle. Audio-video-polysomnographic recordings in the sleep laboratory were made before, at four weeks after, and at 12 weeks after injection. Sleep and SB parameters were scored according to the diagnostic and coding manual of American Academy of Sleep Medicine. The change of sleep and SB parameters were investigated using repeated measures analysis of variance (RM-ANOVA). Twenty-three subjects completed the study (placebo group 10, treatment group 13). None of the SB episode variables showed a significant time and group interaction (p > 0.05) except for electromyography (EMG) variables. The peak amplitude of EMG bursts during SB showed a significant time and group interaction (p = 0.001). The injection decreased the peak amplitude of EMG bursts during SB only in the treatment group for 12 weeks (p < 0.0001). A single BoNT-A injection cannot reduce the genesis of SB. However, it can be an effective management option for SB by reducing the intensity of the masseter muscle.

Keywords: botulinum toxin; polysomnography; sleep bruxism.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Study flowchart. BoNT-A, botulinum toxin type A; OSA, obstructive sleep apnea.
Figure 2
Figure 2
The change of amplitude of EMG burst in the masseter muscle during MVC (A) and RMMA (B). Graphs show significant time and group interactions. The amplitude of EMG burst in the masseter muscle during MVC and RMMA significantly decreased only in the treatment group for 12 weeks. MVC, maximal voluntary clenching; RMMA, rhythmic masticatory muscle activity.
See this image and copyright information in PMC

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